Zimmer Biomet is recalling the SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators due to higher than allowed levels of potential harmful chemicals, which may be toxic to tissues and organs (cytotoxicity) and that were found during the company’s routine monitoring procedure. A cytotoxicity test is a part of the biological evaluation of medical devices to ensure compatibility with the device and the human body. A positive cytotoxicity test (failed result) can indicate that a device contains potential harmful chemicals at amounts or levels that could be dangerous to the patient.
The use of affected product may cause serious adverse health consequences, including but not limited to chronic infections, long-term hospitalization due to additional surgical procedures, paralysis, and death.
- See theRecall Notice for a list of affected serial numbers.
- Distribution Dates: March 28, 2017 to April 6, 2017
- Manufacturing Dates: October 11, 2016 to January 18, 2017
AstraZeneca is notifying physicians and consumers that it is voluntarily recalling one lot of professional (physician) sample bottles containing eight tablets of Brilinta (ticagrelor) 90mg tablets as a precautionary measure. This voluntary recall follows a report that a professional sample bottle containing eight tablets of Brilinta 90mg also contained another medicine called Zurampic (lesinurad) 200 mg tablets which is also manufactured by AstraZeneca.
Unintentional dosing with Zurampic has the potential to lead to adverse renal effects including acute renal failure which is more common when Zurampic is given alone as it should be used in combination with a xanthine oxidase inhibitor. Brilinta has a warning in its prescribing information regarding discontinuation of the medicine. Missed doses of Brilinta increases the risk of heart attack and stroke. People who are treated with a stent and miss doses of Brilinta have a higher risk of getting a blood clot in the stent, having a heart attack, or death. Patients should not stop taking Brilinta without talking to their prescribing doctor. To date, AstraZeneca has not received any reports of adverse events related to this recall.
Abbott has initiated a voluntary recall of specific lots of three catheters: NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter. Specific lots of affected product were manufactured between Jan. 1, 2015 – Jan. 2, 2017, and were distributed between Jan. 13, 2015 – March 14, 2017. For more information, please see Abbott’s field safety notice .
Products from the identified lots may exhibit difficulty in removing the protective balloon sheath, which could cause problems with inflating or deflating the balloon. Potential risks associated with balloon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardial infarction. In one reported case, failure to deflate the balloon necessitated surgery, which resulted in multiple post-surgical complications leading to death.
Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.
Final results from two clinical trials – the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) – showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment. Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs. See the FDA Drug Safety Communication for additional information, including a data summary.
The FDA issued warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer.
It is a violation of the Federal Food, Drug and Cosmetic Act to market and sell products that claim to prevent, diagnose, treat, mitigate or cure diseases without first demonstrating to the FDA that they are safe and effective for their labeled uses. The illegally sold products cited in the warning letters include a variety of product types, such as pills, topical creams, ointments, oils, drops, syrups, teas and diagnostics (such as thermography devices). They include products marketed for use by humans or pets that make illegal, unproven claims regarding preventing, reversing or curing cancer, killing/inhibiting cancer cells or tumors, or other similar anti-cancer claims. See the list of illegally sold cancer treatments.
Mylan N.V. (NASDAQ, TASE: MYL) today announced that Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner for EpiPen® Auto-Injector, has expanded a voluntary recall of select lots of EpiPen (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors to now include additional lots distributed in the U.S. and other markets in consultation with the U.S. Food and Drug Administration (FDA). Read the bulletin for exact lots and photos of product.
FDA has updated its understanding of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) to reflect the agency’s concurrence with the World Health Organization designation of BIA-ALCL as a rare T-cell lymphoma that can develop following breast implants. At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces. BIA-ALCL is a rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma. The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global implant sales data.
See the FDA Update for additional information, including a summary of Medical Device Reports and medical literature, and recommendations for patient care.
The FDA is informing health care providers treating patients with Absorb GT1 Bioresorbable Vascular Scaffold (BVS) that there is an increased rate of major adverse cardiac events observed in patients receiving the BVS, when compared to patients treated with the approved metallic XIENCE drug-eluting stent.
The FDA’s initial review of two-year data from the BVS pivotal clinical study (the ABSORB III trial) shows an 11 percent rate of major adverse cardiac events (e.g., cardiac death, heart attack, or the need for an additional procedure to re-open the treated heart vessel) in patients treated with the BVS at two years, compared with 7.9 percent in patients treated with the already-approved Abbott Vascular’s metallic XIENCE drug-eluting stent (p = 0.03). This study also shows a 1.9 percent rate of developing blood clots (thrombosis) within the BVS versus 0.8 percent within the XIENCE stent at 2 years. These observed higher adverse cardiac event rates in BVS patients were more likely when the device was placed in small heart vessels.
The FDA is working with Abbott Vascular, Inc. to conduct additional analyses to better understand the cause(s) of the higher cardiac event and device thrombosis rates in patients treated with BVS compared to the XIENCE stent. The FDA will continue to monitor the performance of the BVS in ongoing clinical studies and in reports submitted to FDA through MedWatch. We will update this communication when additional information or analyses become available.
The U.S. Food and Drug Administration (FDA) is warning that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. An FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death. Pancreatitis may be caused by spasm of a certain digestive system muscle in the small intestine. As a result, we are working with the Viberzi manufacturer, Allergan, to address these safety concerns. Click the link for more information.
Medtronic is recalling the SynchroMed Implantable Infusion Pumps because a software problem may cause unintended delivery of drugs during a priming bolus procedure, used to quickly deliver large dose of medication from the device to the patient’s spine. During this procedure, patients may receive the drug unintentionally at a high rate of infusion in the cerebrospinal fluid followed by a period of reduced drug delivery after the priming bolus. This can result in a drug overdose or under dose which can lead to serious adverse health consequences such as respiratory depression, coma or death.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- The LIFEPAK 1000 defibrillator
- Affected Product Part Numbers: 320371500XX
- Serial Numbers: There are 133,330 affected serial numbers. Search Affected Devices
- Distribution Dates: June 30, 2006 to December 23, 2016
- Manufacturing Dates: June 30, 2006 to December 20, 2016
- Devices Recalled in the U.S.: 50,046 nationwide
Advanced Pharma, Inc. d/b/a Avella of Houston, is conducting a voluntary recall of all unexpired sterile injectable products labeled “latex free” that were produced at Advanced Pharma, Inc.’s Houston location between September 1, 2016 and February 16, 2017 to the user level (hospitals and institutions) because such products may contain synthetic latex and/or natural latex.
Avella and Advanced Pharma have been unable to confirm with clarity whether its “latex free” label statements are accurate in all cases. The risk of potential adverse events related to a latex allergy, while rare, can range from local site reactions including swelling and inflammation, to allergic reactions which could be life-threatening to users who are sensitive to latex.
Customers in AL, AZ, CA, CO, CT, DE, FL, GA, MS, NC, NJ, OH, OK, OR, PA, SC, TN, TX, UT, or VA that have any of the affected medications labeled with “latex free” that are being recalled should immediately discontinue use and return the unused portion to Avella Specialty Pharmacy. For a full list of Advanced Pharma products, please visit www.AdvancedPharma.com .
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. The recall was issued 12/15/16. Please click on this link for the most updated information.
DA is warning that rare but serious allergic reactions have been reported with the widely used skin antiseptic products containing chlorhexidine gluconate. Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years. See the FDA Drug Safety Communicationfor a data summary.
As a result, FDA is requesting the manufacturers of over-the-counter (OTC) antiseptic products containing chlorhexidine gluconate to add a warning about this risk to the Drug Facts labels.
Hospira, Inc. is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP (NDC: 0409-6510-01, Lot 591053A, Expiry Date 1NOV2017), to the hospital/retail level due to a confirmed customer report for the presence of particulate matter within a single vial. The product is packaged in a carton containing 1×100 mL vial. The lot was distributed from August 2016 through September 2016 in the United States.
If particulate is administered to a patient, it may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response to the particulate. The risk is reduced by the possibility of detection, as the label contains a clear statement directing the physician to visually inspect the product for particulate matter and discoloration prior to administration.
Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. Inform health care professionals in your organization of this recall. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you.
The FDA has received reports of serious adverse events, including patient injury and death, associated with the use of implantable infusion pumps in the MR environment. These reports describe medication dosing inaccuracies (e.g., over-infusion or under-infusion, unintended bolus) and other mechanical problems with the pump (e.g., motor stall, pump not restarting after a Magnetic Resonance Imaging (MRI) exam).
MRI systems provide images of the internal structures of the body that can be useful in diagnosing a wide variety of diseases and conditions. However, the MR environment presents safety hazards for patients with implantable infusion pumps. Only implantable infusion pumps labeled as MR Conditional may be used safely within an MR environment, and only under the specified conditions of safe use. The specific conditions that health care practitioners and patients should follow before, during, and after the MRI exam vary by the make and model of the implantable infusion pump system. Importantly, each implantable pump model may have unique conditions that must be followed in order for a patient to safely undergo an MRI exam. Failure to adhere to these conditions can result in serious injury or death.
The FDA is providing information and recommendations regarding St. Jude Medical’s radio frequency (RF)-enabled implantable ardiac devices and Merlin@home Transmitter to reduce the risk of patient harm due to cybersecurity vulnerabilities. The FDA has reviewed information concerning potential cybersecurity vulnerabilities associated with St. Jude Medical’s Merlin@home Transmitter and has confirmed that these vulnerabilities, if exploited, could allow an unauthorized user, i.e., someone other than the patient’s physician, to remotely access a patient’s RF-enabled implanted cardiac device by altering the Merlin@home Transmitter. The altered Merlin@home Transmitter could then be used to modify programming commands to the implanted device, which could result in rapid battery depletion and/or administration of inappropriate pacing or shocks.
There have been no reports of patient harm related to these cybersecurity vulnerabilities
Based on an FDA review of a large clinical trial that FDA required the drug companies to conduct, FDA determined the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) is lower than previously suspected. The risk of these mental health side effects is still present, especially in those currently being treated for mental illnesses such as depression, anxiety disorders, or schizophrenia, or who have been treated for mental illnesses in the past. However, most people who had these side effects did not have serious consequences such as hospitalization. The results of the trial confirm that the benefits of stopping smoking outweigh the risks of these medicines. See the Drug Safety Communication for a data summary.
As a result of the large clinical trial review, FDA is removing the Boxed Warning, FDA’s most prominent warning, for serious mental health side effects from the Chantix drug label. The language describing the serious mental health side effects seen in patients quitting smoking will also be removed from the Boxed Warning in the Zyban label. FDA is also updating the existing warning section in both labels that describes the side effects on mood, behavior, or thinking to include the results from the clinical trial. This decision is consistent with the recommendations of external experts at a September 2016 FDA Advisory Committee meeting. The patient Medication Guide that explains the risks associated with the use of the medicines will continue to be provided with every patient prescription; however, the risk evaluation and mitigation strategy (REMS) that formally required the Medication Guide will be removed.
Raritan Pharmaceuticals, a contract manufacturer for Homeolab USA, is voluntarily recalling homeopathic products containing belladonna extract (see products below) due to the potential for variation in the content of belladonna extract in the products. The FDA has tested some products and recovered varying levels of belladonna extract content from what is declared on the label.
BACKGROUND: Raritan Pharmaceuticals is a contract manufacturer of these products for Homeolab USA that supplies the belladonna blends to Raritan Pharmaceuticals. These products were distributed Nationwide: 1) Product: CVS Homeopathic Infants’ Teething Tablet 135 tablets, UPC: 050428424162, Lots: 41116 and 43436; 2) Product: Kids Relief Homeopathic Ear Relief Oral Liquid 0.85 fl. oz., UPC: 778159090639, Lot: 35254 3) Product: CVS Homeopathic Kids’ Ear Relief Liquid 0.85 fl. oz., UPC: 050428441633, Lot: 33149.
RECOMMENDATION: Consumers with any product being recalled should stop using the product. Consumers with questions regarding this recall can contact Raritan Pharmaceuticals by phone at 1-866-467-2748 (Monday-Friday from 8am to 5:30pm EST). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Tri-Coast Pharmacy Inc. is voluntarily recalling all sterile products prepared between May 17, 2016 and November 17, 2016 and that remain within expiry due to FDA concerns over the lack of sterility assurance of the drugs named in this recall.
Administration of a drug product intended to be sterile that has microbial contamination has the potential to result in serious infections which may be life-threatening. No portion of any lot of these medications has been found to be non-sterile, but the FDA is concerned that the conditions under which they were produced introduce a lack of sterility assurance for these products.
See the press release for a list of affected products.
Love My Tru Body is voluntarily recalling all of Skinny Bee Diet 500 mg to the consumer level after FDA laboratory testing found Skinny Bee Diet to contain sibutramine, desmethylsibutramine, and/phenolphthalein.
Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Desmethylsibutramine is an active metabolite of sibutramine. Sibutramine and its active metabolites substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Phenolpthalein was previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is no longer marketed in the U.S. These undeclared ingredients make this product an unapproved new drug for which safety and efficacy have not been established.
Ton Shen Health of Chicago, IL, is recalling its Life Rising brand “Side Head Regulator TT” Tablets because they have tested positive for elevated levels of lead for children under the age of 18. Lead is a naturally occurring element which can affect multiple body systems and is particularly harmful to young children. Recent lab tests indicate certain lots of TT product have elevated levels of lead above the currently recognized acceptable levels for children. Lead poisoning can happen if a person is exposed to high levels of lead over short periods of time.
People with high blood levels of lead may show no symptoms, but the condition may cause damage to the nervous system and internal organs. Acute lead poisoning may cause a wide range of symptoms, including abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Children are particularly vulnerable to lead poisoning.
If a child is exposed to enough lead for a protracted period of time (e.g., weeks to months) permanent damage to the central nervous system can occur. This can result in learning disorders, developmental defects, and other long-term health problems. The extent of the functional detriment is dependent on the duration and degree of exposure.
FDA approved class-wide labeling changes for all prescription testosterone products, adding a new Warning and updating the Abuse and Dependence section to include new safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other AAS.
The new Warning will alert prescribers to the abuse potential of testosterone and the serious adverse outcomes, especially those related to heart and mental health that have been reported in association with testosterone/AAS abuse. In addition to the new Warning, all testosterone labeling has been revised to include information in the Abuse and Dependence section about adverse outcomes reported in association with abuse and dependence of testosterone/AAS, and information in the Warning and Precautions section advising prescribers of the importance of measuring serum testosterone concentration if abuse is suspected.
Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) by St. Jude Medical: FDA Safety Communication – Batteries May Fail Earlier Than Expected 10/24/2016
FDA and St. Jude Medical are alerting patients, patient-caregivers, and physicians to respond immediately to Elective Replacement Indicator (ERI) alerts. Due to problems with these batteries, patients do not have the normal 3-month lead time for device replacement. Some batteries have run out within 24 hours of the patient receiving an ERI alert. St. Jude Medical has initiated a recall and correction of the affected devices. See the FDA Safety Communication for a listing of affected devices and data summary.
St. Jude Medical has reported that in some cases, full battery drainage can occur within a day to a few weeks after the patient receives an ERI alert. If the battery runs out, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death. The patients most at risk are those with a high likelihood of requiring life-saving shocks and those who are pacemaker dependent.
Battery depletion may not always be reported to the manufacturer, therefore the true number of devices with premature battery depletion due to lithium clusters is not known. At this time, 349,852 affected devices remain actively implanted worldwide.
The FDA will continue to monitor affected St. Jude Medical ICD and CRT-D devices for any adverse events related to premature battery depletion or cybersecurity vulnerabilities, and the agency will keep the public informed as new information becomes available.
HeartWare Inc. is recalling the HVAD pumps due to a design problem with the driveline connector. The driveline is a tube that connects the HVAD’s pump to the external controller and power source. Contamination of the driveline may result in fluid or other material entering the pump and causing electrical issues or pump stops that may lead to serious adverse health consequences, including death.
The FDA is concerned about the risks to patients from the use of devices manufactured and sold by Multidata Systems International Corporation (“Multidata”).
The FDA knows of at least two Multidata medical devices that the company manufactured and distributed in the United States for which FDA never received nor reviewed 510(k) premarket notifications. These devices include: (1) accessories to radiation therapy devices including the Real Time Dosimetry (RTD) Waterphantom System and (2) the Dual Channel Electrometer. In addition, Multidata has not registered or listed their devices with the FDA, as required by federal law.
- Discontinue the use of any devices manufactured by Multidata and dispose of them appropriately.
- Use accessories to radiation therapy devices and radiation treatment planning software that have been cleared by the FDA. Registered manufacturers of these types of devices are listed under the IYE product code in the FDA’s Registration and Listing Database.
- Follow quality assurance procedures to verify treatment plans by independent means, which may include manual calculations or measurements of radiation doses.
- Report any adverse events related to Multidata devices that come to your attention. Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (“MDR”) regulations. Health care personnel employed by facilities that are subject to FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
The U.S. Food and Drug Administration (FDA) is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus. In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death.
DePuy Synthes is recalling the Adaptor and Light Adaptor for their SBD and SBD II due to a potential for the adaptors to produce extreme internal pressure, which may cause the device to explode. The use of affected products may cause serious adverse health consequences, including death. Recalled products:
- Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II
- Serial Numbers: 05.001.024 and 05.001.108
- Manufacturing Dates: October 6, 2005 to April 5, 2016
- Distribution Dates: January 2006 to June 2016
- Devices Recalled in the U.S.: 451 units distributed nationwide
Virtus Pharmaceuticals Opco II, LLC (Virtus) is voluntarily recalling seven batches of Hyoscyamine sulfate (0.125mg) to the consumer level which include the tablet, sublingual, and orally disintegrating tablet form. This recall is being initiated due to both superpotent and subpotent test results. All of these batches were manufactured by Pharmatech LLC for distribution by Virtus throughout the United States and Puerto Rico. See the press release for a listing of affected batch numbers.
Taking a product that is superpotent could result in hot/dry skin, fever, blurred vision, sensitivity to light, dry mouth, unusual excitement, fast or irregular heartbeat, dizziness, an inability to completely empty the bladder, and seizures. The severity of the adverse event would depend on how superpotent the tablet was. Adverse events such as clotted blood within the tissues and fractures could occur, as a result of falls from dizziness or seizures if the strength is particularly high. To date, Virtus has received three adverse event reports involving hallucinations, stroke-like symptoms, confusion, dizziness, blurred vision, dry mouth, slurred speech, imbalance, and disorientation.
Novo Nordisk Inc. is recalling six batches of the GlucaGen HypoKit in the U.S. due to two customer complaints from the UK and Portugal involving detached needles on the syringe with Sterile Water for Injection (SWFI). A syringe with a detached needle cannot be used as prescribed. Untreated hypoglycemia can eventually lead to unconsciousness and seizures, which can prove fatal. If the blood glucose levels are not quickly restored, continuing hypoglycemia can lead to a decline in brain glucose levels which manifests through a variety of symptoms including cognitive dysfunction, sweating, tremors, convulsion and eventually coma or death.
This recall includes GlucaGen HypoKit batch numbers:
- Batch: FS6X270, Expiry: 09/30/2017
- Batch: FS6X296, Expiry: 09/30/2017
- Batch: FS6X538, Expiry: 09/30/2017
- Batch: FS6X597, Expiry: 09/30/2017
- Batch: FS6X797, Expiry: 09/30/2017
- Batch: FS6X875, Expiry: 09/30/2017
An FDA review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths. Opioids are used to treat pain and cough; benzodiazepines are used to treat anxiety, insomnia, and seizures. In an effort to decrease the use of opioids and benzodiazepines, or opioids and other CNS depressants, together, FDA is adding Boxed Warnings, our strongest warnings, to the drug labeling of prescription opioid pain and prescription opioid cough medicines, and benzodiazepines. See the Drug Safety Communication for a listing of all approved prescription opioid pain and cough medicines, and benzodiazepines and other CNS depressants.
Ton Shen Health/Life Rising Corporation is expanding its recall of “DHZC-2” Tablets to all lots purchased before August 24, 2016 because they have the potential to be contaminated with elevated levels of lead. The recalled “DHZC-2” tablets were sold nationwide in retail stores and distributed through mail orders.
The product comes in a 1.6 ounce bottle, UPC: 616042102727
FDA is currently investigating 6 cases of adverse effects involving individuals taking DHZC-2 supplement tablets. The potential for contamination was noted after FDA notice of higher level of lead presence in DHZC-2 samples from lot #2163-844.
Over the course of the past two years, Alere invested in the research and development of software enhancements to address the potential, in certain cases, of the system to deliver a result that differs from that of another measurement method.
Although Alere is confident that the software enhancements it developed and submitted to the FDA at the end of 2015 effectively address this issue, the FDA notified the company that it believes the company’s studies do not adequately demonstrate the effectiveness of the software modification and advised Alere to submit a proposed plan to voluntarily remove the INRatio device from the market.
The FDA is informing health care professionals that when using programmable syringe pumps to infuse therapies at low rates (e.g., less than 5 mL per hour, and especially at flow rates of less than 0.5 mL per hour), a lack of flow continuity (i.e., inconsistent rate of delivery) can result in serious clinical consequences, including delay of therapy, over-infusion or under-infusion.
Reports of serious adverse events such as abnormal or unstable blood pressure, anxiety from loss of sedation, and increased pain indicators in critically-ill infants have been associated with lack of flow continuity. The FDA believes that these concerns may extend to all programmable syringe pumps while infusing at low rates. Based on current information, the FDA believes that the overall benefits of programmable syringe pumps outweigh their risks. Moving forward, the FDA has requested that manufacturers make labeling changes to their syringe pumps to address flow continuity concerns.
Arbor Pharmaceuticals, LLC announced a voluntary recall of three (3) lots of Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, due to an inadequate seal of the blister pack. An inadequate seal could result in an increase of oxygen and moisture entering the blister cavity which can start the effervescent process. This results in enlarged and swelled tablets which could also completely dissolve within the blister pack.
The improper seal of the product can lead to a potentially sub-therapeutic dose as well as potential microbial contamination. Because the effectiveness of acetylcysteine to prevent or lessen hepatic injury after ingestion of acetaminophen is delayed with decreased therapy, sub-therapeutic dosing could lead to increased risk of liver injury. With regards to the potential microbial contamination due to moisture ingress into the tablets, the risk of serious infection is increased in certain patient populations such as children, pregnant women, immunosuppressed patients, and patients on gastric acid suppression therapy such as proton pump inhibitors.
Three lots of the 500 mg strength (Lot Numbers 005C16, 006C16, and 007C16, expiration date 02/2018) with NDC 24338-700-10 are included in the recall.
DSM Biomedical B.V., the Netherlands, Cook Medical’s supplier of hydrophilic coating for the Roadrunner Uniglide Hydrophilic Wire Guide, recalled certain lots of material due to concerns about a potential contamination by glass particles ranging in size of approximately 4 to 280 µm. Cook received one lot of the affected recalled coating. This prompted Cook Medical to initiate a recall of 8,750 units of the Roadrunner UniGlide Hydrophilic Wire Guides on June 24, 2016. Cook is taking this action as a precautionary measure, because it cannot exclude the possibility that glass particles passed through during processing and could be present in the coating of the recalled wire guide units.
Potential adverse events that may occur as a result of this contamination could include vessel damage, bleeding and embolic particulate in the circulatory system. Cook Medical has not received any reports of adverse events of these types to date.
Dräger discovered that the check valve on the circuit may leak. This could result in the patient re-breathing exhaled gas with reduced oxygen concentration and increased carbon dioxide levels. This can lead to serious health consequences, including excessive carbon dioxide in the bloodstream (hypercapnia) and increased acidity in the blood (acidosis), which could lead to death.
This issue pertains only to the VentStar Oxylog 3000 Disposable Pediatric Patient Circuit. There is no issue or problem with the Oxylog 3000/3000 plus ventilator.
Teva Pharmaceuticals announced a voluntary recall of seven lots of Amikacin Sulfate Injection USP, 500 mg/2mL (250 mg/mL) and 1 gram/4mL (250 mg/mL) vials due to the potential for the presence of glass particulate matter. The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening if a critical organ is affected. See the press release for a listing of affected lot numbers.
Including the following currently available fluoroquinolones
Cipro extended-release (ciprofloxacin extended-release)
Ofloxacin (generic brand)
FDA approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, FDA revised the Boxed Warning, FDA’s strongest warning, to address these serious safety issues. In addition, FDA updated other parts of the drug label including the Warnings and Precautions and Medication Guide sections.
FDA has determined that fluoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections because the risk of these serious side effects generally outweighs the benefits in these patients. For some serious bacterial infections the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option.
HCG and Sermorelin by Talon Compounding Pharmacy: Recall – Lack of Sterility Assurance 07/22/2016
alon Compounding Pharmacy (TCP) voluntarily recalled all lots of lyophilized HCG and sermorelin aseptically compounded and packaged by TCP and that remain within expiry due to FDA concern over a lack of sterility assurance. Administration of a sterile drug product intended to be sterile that is compromised can result in health hazards including risk of serious infection or other complications.
The sterile products were distributed to patients and providers nationwide between January 18 and July 18, 2016.
The FDA is investigating reports of hair loss, hair breakage, balding, itching, and rash associated with the use of WEN by Chaz Dean Cleansing Conditioner products.
While the FDA continues its investigation, consumers should be aware of reactions reported in association with the use of WEN by Chaz Dean Cleansing Conditioner products. Consumers who experience a reaction after using WEN by Chaz Dean Cleansing Conditioner products should stop using the product and consult with their dermatologist or other health care provider. The agency also urges consumers to report to FDA any reactions they may have experienced when using these products.
The FDA has not yet determined a possible cause for the adverse events that have been reported, and will provide additional updates as new information becomes available.
The FDA is alerting health care professionals that PharmaTech LLC, Davie, Florida, is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories, Livonia, Michigan. The agency confirmed the product has been contaminated with Burkholderia cepacia, a bacteria linked to an outbreak in five states.
In addition, FDA has received several adverse event reports of B. cepacia infections in patients. Some of these reports identify liquid docusate sodium products manufactured by companies other than PharmaTech. FDA and the Centers for Disease Control and Prevention continue to investigate the extent of this issue in order to identify other potentially contaminated liquid docusate sodium products.
Recalled Device and Discontinuation of the Product line:
- Alere plans to remove the INRatio® and INRatio®2 PT/INR Monitoring System, which includes the INRatio® or INRatio2® PT/INR Monitor and the INRatio® Test Strips, from the market and discontinue manufacture of the product line
- All serial and lot numbers: 0100071, 0100139, 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5, 99008G7, 0100004, 0100007, 0100137, 0200431, 0200432, 0200433, 0200457, 55128A
- Manufacturing and distribution dates: Monitor distribution from April 1, 2008; Test Strip kits distributed from April 1, 2008 to July 8, 2016
- Complete list of affected devices
- Devices recalled in the U.S.: 125,5765 Test Strip kits (12 count), 24,783 Test Strip kits (48 count), 236,345 INRatio® or INRatio2® Monitors
FDA has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.
UPDATED 06/13/2016: Zecuity manufacturer Teva Pharmaceuticals has decided to temporarily suspend sales, marketing, and distribution to investigate the cause of burns and scars associated with the Zecuity patch. Health care professionals should discontinue prescribing Zecuity, and patients should stop using any remaining patches and contact their prescribers for an alternative migraine medicine.
FDA is investigating the risk of serious burns and potential permanent scarring with the use of Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine headaches. Since marketing of the Zecuity patch began in September 2015, a large number of patients have reported they experienced burns or scars on the skin where the patch was worn. The reports included descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin. As a result, FDA is investigating these serious adverse events to determine whether future regulatory action is needed, and will update the public with new information when the FDA review is complete.
FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death. The risk of these serious heart problems, including abnormal heart rhythms, may also be increased when high doses of loperamide are taken with several kinds of medicines that interact with loperamide (see Examples of Drugs that Can Potentially Interact with Loperamide, in the FDA Drug Safety Communication).
The majority of reported serious heart problems occurred in individuals who were intentionally misusing and abusing high doses of loperamide in attempts to self-treat opioid withdrawal symptoms or to achieve a feeling of euphoria. FDA continues to evaluate this safety issue and will determine if additional FDA actions are needed.
The FDA is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. Many other products for these conditions are available that do not contain aspirin.
These widely used products already contain warnings about this bleeding risk on their labels; however, we are continuing to receive reports of this serious safety issue. As a result, we will continue to evaluate this safety concern and plan to convene an advisory committee of external experts to provide input regarding whether additional FDA actions are needed.
FDA is investigating the risk of serious burns and potential permanent scarring with the use of Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine headaches. Since marketing of the Zecuity patch began in September 2015, a large number of patients have reported they experienced burns or scars on the skin where the patch was worn. The reports included descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin. As a result, FDA is investigating these serious adverse events to determine whether future regulatory action is needed, and will update the public with new information when the FDA review is complete.
FDA is warning health care professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and nail fungal infections. Use of this medication carries the risk of serious liver damage, adrenal gland problems, and harmful interactions with other medicines that outweigh its benefit in treating these conditions, which are not approved uses of the drug.
FDA approved label changes for oral ketoconazole tablets in 2013 to reflect these serious risks and to remove the indications for treatment of skin and nail fungal infections. However, an FDA safety review found that oral ketoconazole continues to be prescribed for these types of conditions. Since the 2013 labeling change, one patient death has been reported to the FDA due to liver failure associated with oral ketoconazole prescribed to treat a fungal infection of the nails. See the full Drug Safety Communication for further information.
FDA Drug Safety Communication: Interim clinical trial results find increased risk of leg and foot amputations, mostly affecting the toes, with the diabetes medicine canagliflozin (Invokana, Invokamet); FDA to investigate 05/18/2016
The U.S. Food and Drug Administration (FDA) is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (Invokana, Invokamet). We have not determined whether canagliflozin increases the risk of leg and foot amputations. We are currently investigating this new safety issue and will update the public when we have more information.
FDA is warning that the antipsychotic medicine olanzapine can cause a rare but serious skin reaction that can progress to affect other parts of the body. FDA is adding a new warning to the drug labels for all olanzapine-containing products that describes this severe condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
A search of the FDA Adverse Event Reporting System (FAERS) database identified 23 cases of DRESS reported with olanzapine worldwide since 1996, when the first olanzapine-containing product was approved. FAERS includes only reports submitted to FDA, so there are likely to be additional cases about which FDA is unaware. One patient taking olanzapine experienced DRESS and died; however, this patient was taking multiple medicines that could also have contributed to death (see the Data Summary section of the Drug Safety Communication for more information).
DRESS may start as a rash that can spread to all parts of the body. It can include fever and swollen lymph nodes and a swollen face. It causes a higher-than-normal number of infection-fighting white blood cells called eosinophils that can cause inflammation, or swelling. DRESS can result in injury to organs including the liver, kidneys, lungs, heart, or pancreas, and can lead to death. DRESS is a potentially fatal drug reaction with a mortality rate of up to 10%.
Boston Scientific has initiated a global, voluntary recall of all models of its Fetch 2 Aspiration Catheter, a thrombectomy catheter used during procedures to remove small blood clots from coronary arteries. The Fetch 2 catheters were recalled on March 22, 2016, due to complaints of shaft breakage.
All reports of shaft breakage happened during the procedure, and the broken section was either removed while still partially attached to the catheter shaft or retrieved with a snare, without further patient complications.
FDA is alerting health care professionals not to use any drug products that are intended to be sterile and are produced and distributed nationwide by Pharmakon Pharmaceuticals Inc., in Noblesville, Indiana, due to a lack of sterility assurance and other quality issues.
Vascular Solutions, Inc. initiated a nationwide recall of Guardian II hemostasis valves used in catheterization procedures. The recalled products are specific lots of Model Numbers 8210 and 8211. The products have been recalled because they pose an increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death.
The recalled products were manufactured from March 2015 to February 2016 and distributed from April 2015 to February 2016. This recall only affects the Guardian II hemostasis valves and does not include the Guardian II NC hemostasis valves.
Dexcom Inc. is recalling the Continuous Glucose Monitoring Systems because the audible alarm may not activate in the receiver piece when low or high glucose levels (hypoglycemia or hyperglycemia) are detected. Relying on this product for notification of low or high blood sugar could result in serious adverse consequences, including death as the auditory alarm may not sound and users might not be notified of low or high blood sugar.
Recalled Devices include (all model numbers and all lot numbers): Dexcom G4 PLATINUM Receiver, Dexcom G4 PLATINUM (Pediatric) Receive, Dexcom G4 PLATINUM (Professional) Receiver, Dexcom G4 PLATINUM Receiver with Share, Dexcom G4 PLATINUM (Pediatric) Receiver with Share, Dexcom G5 Mobile Receiver.
An FDA safety review has found that type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. As a result, FDA is adding new warnings to the drug labels about this safety issue.
B. Braun Medical Inc. is recalling one lot of 5% Dextrose Injection USP 100/150mL container (Lot #J5J706, catalog #S5104-5264, NDC 0264-1510-32) to the consumer level. B. Braun recently identified an adverse quality trend in customer complaints reporting that some containers in lot J5J706 exhibited leakage and, in a few instances, visible particulate matter identified to be microbial growth.
Today, the U.S. Food and Drug Administration announced a proposal to ban most powdered gloves in the United States. While use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them, which cannot be corrected through new or updated labeling.
Dräger is recalling the Oxylog Emergency Transport Ventilators because an electrical issue may cause the device to stop working if the control knobs (adjustment potentiometers) are not regularly used. See the Recall Notice for affected devices and catalog numbers.
If the device operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death.
FDA is warning consumers not to use “Bentonite Me Baby” by Alikay Naturals because of a potential lead poisoning risk. FDA laboratory analysis of the product found elevated lead levels. Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system. In children, chronic exposure to lead, even at low levels, is associated with impaired cognitive function, including reduced IQ, behavioral difficulties, and other problems. See the FDA Consumer Warning for a product photo.
St. Jude is recalling the Optisure leads due to a manufacturing error that may have caused damage to the insulation layer of one of the shock coils. Depending on device programming and the depth of the cut, this could result in the inability of the defibrillator to deliver electrical therapy to the patient. The use of affected products may cause serious adverse health consequences, including patient injury or death. See the Recall Notice for a listing of affected product codes.
Manufacturing dates: March 12, 2014 to March 22, 2015
Distribution dates: April 9, 2014 to October 20, 2015
Abbott’s Compounding Pharmacy is voluntarily recalling all unexpired lots of sterile compounded products due to concerns of lack of sterility assurance. All unexpired lots are subject to the recall. These include injectable medications, sterile solutions, eye drops, and eye ointments. All recalled products were distributed to patients, physician offices and clinics, and veterinarians within California.
The FDA is warning consumers not to use Licorice Coughing Liquid, a cough syrup product sold over-the-counter, because it contains unidentified morphine.
The cough syrup’s labeling contains information written in English and Chinese. The product labeling does not identify the presence of morphine in English. With unidentified morphine, consumers who are hypersensitive to morphine could suffer severe allergic reactions if they take this product. Other effects of morphine can include, but are not limited to, respiratory depression and death.
Consumers should not purchase this cough syrup and anyone who has this product should not use it.
This product is manufactured by Ma Ying Long Pharmaceutical Group in China and distributed in the U.S. by Master Herbs USA, Inc. in Pomona, CA. The distributor has agreed to recall the product.
This product is available on-line and in some retail stores.
Perrigo Company announced that, following the recent recall of certain dosing cups by its supplier, it has initiated a voluntary product recall in the US to the retail level of 2 batches of its children’s guaifenesin grape liquid (100mg/5 mL) and 3 batches of its children’s guaifenesin DM cherry liquid (100mg guaifenesin and 5mg dextromethorphan HBr/ 5 ml) sold in 4 oz. bottles with dosage cup in a box under multiple store brand product names. Some packages contain an oral dosing cup with incorrect dose markings. See the press release for affected label and lot numbers.
At risk populations such as those who are poor metabolizers of dextromethorphan may experience an overdose by a factor of 3, if incorrect measuring levels are used.
Consumers should be aware that an overdose of Guaifenesin DM may cause hyper excitability, rapid eye movements, changes in muscle reflexes, ataxia, dystonia, hallucinations, stupor, and coma. Other effects have included nausea, vomiting, tachycardia, irregular heartbeat, seizures, respiratory depression, and death. Small children who are poor metabolizers of dextromethorphan and use the product regularly over a period of several days at the mistaken dose, may develop cumulative toxicity. Moreover, adverse reactions to guaifenesin when given in high or excessive dosage may include nausea/vomiting, diarrhea, and/or abdominal pain. Therefore, an extreme overdose in an at risk population may need medical intervention, but in most cases adverse health consequences are temporary and reversible.
Stryker Sustainability Solutions received two reports that the catheter included in the Drainage Set broke off in the pleural cavity while inserting the device into the patient. Both cases resulted in the need for medical intervention. This issue could cause serious patient injury or death.
See the Recall Notice for further information, including manufacturing dates, distribution dates, and lot numbers.
The U.S. Food and Drug Administration today issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.
The orders will require manufacturers to address safety concerns, including severe pelvic pain and organ perforation, through a rigorous PMA pathway to demonstrate safety and effectiveness. The actions apply only to mesh devices marketed for the transvaginal repair of POP. These orders do not apply to surgical mesh for other indications, like stress urinary incontinence (SUI) or abdominal repair of POP.
Pharmedium Issues Voluntary Nationwide Recall of 4mg Norepinephrine Bitartrate (16mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 8mg Norepinephrine Bitartrate (32mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag for Discoloration. 12/31/2015
PharMEDium Services, LLC is voluntarily recalling 29 lots of 4mg Norepinephrine Bitartrate (16mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 3 lots of 8mg Norepinephrine Bitartrate (32mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag distributed to hospital customers. They received complaints from hospitals for products that have been found to exhibit a slight discoloration in the admixture. Click to see the specific lots and expiration dates.
ioMérieux recallied the Etest PIP/TAZO/CON-4 PTC 256 because the test results from the affected product may indicate that antibiotic therapy using PIP/TAZO could stop or slow the growth of certain bacteria when it may not actually be effective in treating those bacteria. This error may result in inappropriate treatment of a patient’s infection and could cause serious patient health consequences, including increased time in the hospital, unnecessary tests or procedures, treatment failure, sepsis, and even death.
This recall includes all affected products with manufacturing dates December 20, 2012 to October 23, 2015, and distribution dates: January 24, 2013 to November 9, 2015. See the Recall Notice for a listing of affected product reference and lot numbers.
Draeger is recalling the Perseus A500 anesthesia workstation because a faulty power switch may fail, causing the workstation to alarm and shut down unexpectedly. If this occurs, ventilation may fail and the patient may not receive either anesthesia or enough oxygen. This could cause patients to suffer serious adverse health consequences, including injury or death. The recall includes all Draeger Perseus A500 anesthesia workstations manufactured from June 1, 2013 to September 30, 2015 with distribution dates of February 1, 2015 to September 30, 2015. See the FDA Recall Notice for a link to a list of affected serial numbers.
The company has received one report of this issue occurring, with no injuries and no deaths.
Nuway Distributors llc is voluntarily recalling all lots of Apexxx tablets to the consumer level. FDA analysis found Apexxx to contain amounts of the PDE-5 Inhibitor, sildenafil, which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED) making this tainted dietary supplement and unapproved drug. Sildenafil is not listed on the product labels. Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels that may be life threatening. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing.
SmartLipo365 is voluntarily recalling all lots of Smart Lipo (800, 900, 950 mg) capsules to the consumer level. FDA’s analysis found the Smart Lipo products to contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. These products may also interact in life-threatening ways with other medications a consumer may be taking.
Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.
Smart Lipo 365 has not received any complaints associated with this product to date.
Boston Scientific has voluntarily recalled the Chariot Guiding Sheath globally. The recall affects all UPNs of the Chariot Guiding Sheaths. The recall was initiated on November 19, 2015 due to the risk of shaft separation.
To date, Boston Scientific has received fourteen complaints for shaft separation, four of which involved separation of the distal shaft. These events occurred during device preparation or use. The most severe outcome of this failure is embolism of device fragments, which could lead to obstruction of blood flow or additional intervention to remove a device fragment. Obstruction of blood flow can result in injuries such as stroke, kidney damage or damage to the intestines or limbs.
FDA is alerting drug compounders that certain lots of baclofen active pharmaceutical ingredient (API) manufactured by Taizhou Xinyou Pharmaceutical & Chemical Co., Limited (Taizhou) Taizhou City, Zhejiang Province, China, may be at risk for contamination with particulates and should not be used to compound sterile injectable drugs.
Vent Medical is recalling the LS, 5i, or 7i Inspiration ventilators because a faulty switch on the ventilators’ power board may fail, causing the ventilator to shut down without sounding an alarm. If the ventilator shuts down, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death.
This recall includes all models of eVent Medical LS, 5i and 7i Inspiration ventilators manufactured prior to January 21, 2015. Distribution dates: February 14, 2013 to December 31, 2014
An FDA safety review has resulted in adding warnings to the labels of a specific class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors about the risks of too much acid in the blood and of serious urinary tract infections. Both conditions can result in hospitalization.
FDA issued a Drug Safety Communication in May 2015 warning about the risk of ketoacidosis with SGLT2 inhibitors and alerting that the Agency would continue to evaluate this safety issue. A review of the FDA Adverse Event Reporting System (FAERS) database from March 2013 to May 2015 identified 73 cases of ketoacidosis in patients with type 1 or type 2 diabetes treated with SGLT2 inhibitors (see the Drug Safety Communication Data Summary). Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, and trouble breathing.
FDA also identified 19 cases of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that started as urinary tract infections with the SGLT2 inhibitors reported to FAERS from March 2013 through October 2014. All 19 patients were hospitalized, and a few required admission to an intensive care unit or dialysis in order to treat kidney failure.
As a result, FDA added new Warnings and Precautions to the labels of all SGLT2 inhibitors to describe these two safety issues, and to provide prescribing and monitoring recommendations. FDA is also requiring manufacturers of SGLT2 inhibitors to conduct a required postmarketing study. This required enhanced pharmacovigilance study requests that manufacturers perform analyses of spontaneous postmarketing reports of ketoacidosis in patients treated with SGLT2 inhibitors, including specialized follow-up to collect additional information, for a period of 5 years.
On November 2, 2015, Insulet Corporation initiated a lot-specific voluntary Field Safety Notification (Notification) for 15 lots of the OmniPod (Pod) which were distributed in the U.S. and three lots which were distributed internationally. This Notification is due to a slight increase in the reported cases in which the Pod’s needle mechanism failed to deploy or there was a delay in the deployment of the needle mechanism. In the event a needle mechanism fails to deploy, the needle will not be inserted and insulin delivery will not begin. The interruption of insulin delivery may cause elevated blood glucose (hyperglycemia), which, if left untreated, can result in diabetic ketoacidosis (DKA).
The affected Pod lots have resulted in 66 Medical Device Reports, of which three required medical intervention. See the Press Release for a listing of affected product lots.
In accordance with a Consent Decree entered in January 2007 with Custom Ultrasonics, the FDA ordered Custom Ultrasonics to recall all of its Automated Endoscope Reprocessors (AERs) from health care facilities due to the firm’s continued violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), applicable regulations, and the Consent Decree. FDA is recommending that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternative methods to reprocess flexible endoscopes as soon as possible.
As part of the FDA’s ongoing investigation into infections associated with reprocessed medical devices and AER devices used for cleaning and disinfection, the FDA has been reviewing the validation test methods and performance data for all AER manufacturers. To date, Custom Ultrasonics has not demonstrated that its AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection.
The FDA’s most recent inspection of the Custom Ultrasonics’ facility in April 2015 documented continued violations. Violations include the inability to validate that the AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection. The identified violations could result in an increased risk of infection transmission.
The ventilator may stop working without sounding an alarm when the device operator presses the oxygen enrichment key to attach the ventilator mask to the patient (suctioning maneuver). This problem can occur during the following conditions:
- When pressing the oxygen enrichment key a second time within 50 milliseconds after the disconnection is detected, or,
- When disconnection is detected immediately before the oxygen enrichment period automatically ends, so that detection of disconnection and termination of O2-enrichment occur within 50 milliseconds of each other.
If the device operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death.
An FDA review has determined that long-term use of the blood-thinning drug Plavix (clopidogrel) does not increase or decrease overall risk of death in patients with, or at risk for, heart disease. FDA evaluation of the Dual Antiplatelet Therapy (DAPT) trial and several other clinical trials also does not suggest that clopidogrel increases the risk of cancer or death from cancer.
In order to investigate the increased risk of death and cancer-related death reported with clopidogrel in the DAPT trial, FDA examined the results of the DAPT trial and other large, long-term clinical trials of clopidogrel with data available on rates of death, death from cancer, or cancer reported as an adverse event.
FDA performed meta-analyses of other long-term clinical trials to assess the effects of clopidogrel on death rates from all causes. The results indicate that long-term (12 months or longer) dual antiplatelet therapy with clopidogrel and aspirin do not appear to change the overall risk of death when compared to short-term (6 months or less) clopidogrel and aspirin, or aspirin alone. Also, there was no apparent increase in the risks of cancer-related deaths or cancer-related adverse events with long-term treatment.
The identified lots of MPS Delivery sets have shown a possible seal failure along the blood source channel of main pump cassette, resulting in blood loss from the bypass circuit and interruption of cardioplegia solution delivery. The firm has received twenty complaints alleging this seal failure which have resulted in 16 instances of patient blood loss during surgery.
There have been no reports of patient injuries as a result of the alleged issue to date. Recalled Product(s) were manufactured from May 2015 to September 2015 and distributed from June 2015 to September 2015.
The U.S. Food and Drug Administration (FDA) is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. As a result, we are requiring the manufacturer to add new information about this safety risk to the drug labels.
Patients taking these medicines should contact their health care professional immediately if they develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools, as these may be signs of liver injury. Patients should not stop taking these medicines without first talking to their health care professionals. Stopping treatment early could result in drug resistance to other hepatitis C medicines. Health care professionals should closely monitor for signs and symptoms of worsening liver disease, such as ascites, hepatic encephalopathy, variceal hemorrhage, and/or increases in direct bilirubin in the blood.
If you buy imported products marketed as “dietary supplements” and nonprescription drug products from ethnic or international stores, flea markets, swap meets or online, watch out. Health fraud scams abound. According to Cariny Nunez, M.P.H., a public health advisor in the Office of Minority Health at the Food and Drug Administration (FDA), health scammers often target advertising to people who prefer to shop at nontraditional places, especially those who have limited English proficiency and limited access to health care services and information.
“These scammers know that ethnic groups who may not speak or read English well, or who hold certain cultural beliefs, can be easy targets,” Nunez says. For example, Native Americans, Latinos, Asians and Africans may have a long tradition of turning to more herbal or so-called “natural” remedies. Many advertisers put the word “natural” somewhere on the package of a product, knowing it inspires trust in certain groups.
On October 7, 2015, Cook Medical initiated a voluntary recall for select sizes of Beacon® Tip Angiographic Catheters. This recall includes all lots of these select sizes of the Beacon® Tip Angiographic Catheters. This recall is an expansion of the voluntary lot-specific recall issued on July 2, 2015. The products include specific versions of the Torcon NB® Advantage Beacon®Tip Catheters (catalog prefix HNBR4.0, HNBR4.1 and only HNBR5.0 with the RUC suffix), Royal Flush® Plus Beacon®Tip High-Flow Catheters (catalog prefix HNR4.0), and Slip-Cath® Beacon® Tip Hydrophilic Catheters (catalog prefix SCBR4.0, SCBR4.1, and only SCBR5.0 with the RUC suffix), and Shuttle®Select Slip-Cath® catheters (catalog prefix SCBR4.5).
The Beacon Tip Angiographic Catheters have been found to exhibit tip splitting or separation, which has resulted in 42 Medical Device Reports. Tip splitting has the potential to lead to loss of device function. Tip separation may require medical intervention to retrieve a separated segment or, if not retrieved, has the potential to occlude blood flow to end organs.
The U.S. Food and Drug Administration today granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.
“The anticoagulant effects of Pradaxa are important and life-saving for some patients, but there are situations where reversal of the drug’s effects is medically necessary,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval offers the medical community an important tool for managing patients taking Pradaxa in emergency or life-threatening situations when bleeding can’t be controlled.”
The FDA approved Pradaxa in 2010 to prevent stroke and systemic blood clots in patients with atrial fibrillation, as well as for the treatment and prevention of deep venous thrombosis and pulmonary embolism. Praxbind is the first reversal agent approved specifically for Pradaxa and works by binding to the drug compound to neutralize its effect. Praxbind solution is for intravenous injection.
General Mills is voluntarily recalling several days of production of Cheerios and Honey Nut Cheerios cereal produced at its Lodi, California facility on certain dates in July of this year because of an undeclared allergen – wheat – with potential adverse health effects.
Cheerios and Honey Nut Cheerios produced on these dates at the company’s Lodi, California facility are being recalled because an isolated incident resulted in wheat flour being inadvertently introduced into the gluten free oat flour system at its Lodi facility. As a result, the products may contain an undeclared allergen – wheat – in products labeled as gluten-free.
General Mills will recall and retrieve affected cereals produced on those dates from customer warehouses and store shelves. Consumers with wheat allergies, celiac disease or gluten intolerance should not consume products bearing the affected code dates and should contact General Mills for a replacement or full refund.
This voluntary recall includes four days production of original (yellow box) Cheerios, and thirteen days of production of Honey Nut Cheerios at its Lodi, California facility with the following “BETTER IF USED BY” code dates and the plant code LD which indicates the product was produced at Lodi, California:
|Honey Nut Cheerios||Yellow Box Cheerios|
The FDA is aware of recent reports regarding reduced leaflet motion in some bioprosthetic aortic valves, including both SAVR and TAVR devices. Importantly, most cases of reduced leaflet motion were discovered by advanced imaging studies in patients without symptoms of abnormal bioprosthetic valve function. Further, these studies have shown that in valves with reduced motion of one or more individual leaflets, there was acceptable forward blood flow through the valve opening without evidence of stenosis.
The definitive cause(s) of reduced leaflet motion in some bioprosthetic aortic valves also is not known. Evidence from imaging studies suggests that blood clot (thrombus) deposits on the leaflets may cause restricted motion. The prevalence of reduced leaflet motion was less in patients receiving therapeutic anticoagulation with warfarin compared with those receiving sub-therapeutic or no anticoagulation and with those receiving dual anti-platelet therapy.
In one study, treatment with blood thinning medications (anticoagulants) resulted in the resolution of the leaflet motion abnormalities.
At this time, FDA believes that bioprosthetic aortic valves remain reasonably safe and effective when used according to their approved indications. This view is supported by the favorable benefit/risk profile observed in SAVR devices in the 30 years they have been on the market and in TAVR devices in the 8 years they have been in use.
MicroPort Orthopedics Inc. has received reports of an unexpected rate of fractures after surgery related to this specific modular neck. If the modular neck fractures, the patient may experience sudden pain, instability and difficulty walking and performing common task. An acute fracture will require revision surgery to remove and replace the neck and stem components. Acute fracture and emergency revision surgery is a serious adverse health consequence and could lead to neurovascular damage, hematoma, hemorrhage, and even death.
Most cranial perforators are designed to automatically stop drilling after penetrating the skull to prevent the tip from unintentionally drilling or “plunging” into the brain. However, this clutch mechanism may fail to disengage if proper use, patient considerations, and device selection are not followed in accordance with the manufacturer’s instructions for use. The clinical consequences of cranial perforators failing to disengage can be serious. Most cranial perforators are designed to automatically stop drilling after penetrating the skull to prevent the tip from unintentionally drilling or “plunging” into the brain. However, this clutch mechanism may fail to disengage if proper use, patient considerations, and device selection are not followed in accordance with the manufacturer’s instructions for use. The clinical consequences of cranial perforators failing to disengage can be serious.
US Compounding, Inc. is voluntarily recalling all lots of sterile products aseptically compounded and packaged by USC and that remain within expiry due to FDA concern over a lack of sterility assurance. The sterile products were distributed nationwide to patients, providers, hospitals, or clinics between March 14, 2015 and September 9, 2015. If the sterility of a compounded preparation intended to be sterile is compromised, patients may be at risk.
Lucy’s Weight Loss System is voluntarily recalling all lots distributed May 25 – June 23 2015 of Pink Bikini and Shorts on the Beach Blue and Gold Edition, 30 blue capsules (750MG per) capsules and 30 gold capsule (800MG per) capsules to the consumer level. The Pink Bikini and Shorts on the Beach have been found positive for Sibutramine and Phenolphthalein after FDA sampling and testing.
Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. These products may also interact in life-threatening ways with other medications a consumer may be taking.
Lucy’s Weight Loss System has received not received any complaints to date. Lucy’s Weight Loss System has not received any reports of adverse events related to this recall.
FDA is investigating the use of the pain medicine tramadol in children aged 17 years and younger, because of the rare but serious risk of slowed or difficult breathing. This risk may be increased in children treated with tramadol for pain after surgery to remove their tonsils and/or adenoids. FDA is evaluating all available information and will communicate final conclusions and recommendations to the public when the review is complete.
Tramadol is not FDA-approved for use in children; however, data show it is being used “off-label” in the pediatric population. Health care professionals should be aware of this and consider prescribing alternative FDA-approved pain medicines for children.
FDA notified healthcare professionals of a Class I Recall of the Freedom Driver Systems used with the SynCardia temporary Total Artificial Heart (TAH-t). A specific part of the Freedom Driver drive mechanism may fail and cause the device to stop pumping. Patients do not receive any advanced warning that the device may fail. If it does fail, a red light located in the center of the driver, towards the top, will stay red and a loud continuous alarm will sound.
However, if the Freedom Driver stops pumping, the patient will lose consciousness almost immediately, which means that the warning light and alarm may not be helpful. The patient will likely experience serious injury or death if not immediately switched to a backup driver by a caregiver.
The FDA has undertaken an ongoing, comprehensive investigation into infections associated with reprocessed reusable medical devices, working with federal partners, manufacturers, and other stakeholders to better understand the critical factors contributing to device-associated patient infection and how to best mitigate them.
In the March 2015 Reprocessing Final Guidance, FDA identified bronchoscopes as being part of a subset of devices that pose a greater likelihood of microbial transmission and represent a high risk of infection if they are not adequately reprocessed, so FDA is proactively investigating these devices to determine if additional steps should be taken. As part of that investigation, FDA observed commonalities in some of the reports to the FDA regarding infections associated with flexible bronchoscopes. Based on current knowledge, the risk of infection transmission presented by reprocessed bronchoscopes appears to be lower than the risk of infection transmission presented by reprocessed duodenoscopes.
While not every medical device report contains information sufficient to definitively identify the factors contributing to persistent device contamination or device-associated infection, FDA analysis to date has identified two recurrent themes:
• Failure to meticulously follow manufacturer instructions for reprocessing
• Continued use of devices despite integrity, maintenance and mechanical issues.
Bronchoscopes must undergo reprocessing in between patient uses to clean the devices of soil and contaminants and to inactivate microorganisms by disinfection or sterilization. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. If the process is not followed meticulously, the flexible bronchoscope can remain contaminated, potentially resulting in infection transmission from one patient to the next.
FDA Drug Safety Communication: FDA revises label of diabetes drug canagliflozin (Invokana, Invokamet) to include updates on bone fracture risk and new information on decreased bone mineral density 09/15/2015
The U.S. Food and Drug Administration (FDA) has strengthened the warning for the type 2 diabetes medicine canagliflozin (Invokana, Invokamet) related to the increased risk of bone fractures and added new information about decreased bone mineral density. Bone mineral density relates to the strength of a person’s bones. To address these safety concerns, we added a new Warning and Precaution and revised the Adverse Reactions section of the Invokana and Invokamet drug labels.
Iowa Select Herbs manufactured and distributed unapproved new drugs, misbranded drugs, misbranded dietary supplements, and dietary supplements not manufactured in compliance with the current Good Manufacturing Practice regulations for Dietary Supplements, and therefore adulterated. There are no reports to date of side effects or adverse events.
Thoratec Issues Voluntary Device Correction 09/14/2015
Thoratec Corporation issued a voluntary Urgent Medical Device Correction Letter to all hospitals who have patients supported with the HeartMate II LVAS reminding them to monitor the expiration date of the backup battery contained within the HeartMate II “Pocket” System Controller, as specified in the product Instructions for Use
The One Minute Miracle Inc. is voluntarily recalling all lots of Miracle Diet 30, capsules and Miracle Rock 48, capsules to the consumer level. These products have been recalled due to FDA analysis revealing that these dietary supplements contain undeclared drug products making them unapproved drugs.
The battery (part of the PS500 Power Supply Unit) that powers the Evita V500 and Babylog VN500 Ventilators does not last as long as expected. The battery indicator light shows a sufficiently charged battery even when the battery is depleted. When the “battery low” and “battery depleted” alarms sound, the devices do not indicate how much time is left before the ventilator will shut down due to lack of power. Analysis by Dräger indicates that the battery should last approximately 30 minutes. If the power is lost, the 30-minute battery back-up should last until the ventilator is connected to a main power supply.
When the ventilator is in neonatal Volume Control Plus (VC+) mode with active humidification, a software error may cause the amount of air being delivered to the patient (tidal volume) to be lower than the amount programmed by the clinician. If a patient does not receive the amount of air set on the machine, they may need to be removed from the ventilator and placed on a different system. A patient not receiving enough oxygen can result in possible injury or death.
The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines sitagliptin, saxagliptin, linagliptin, and alogliptin may cause joint pain that can be severe and disabling. We have added a new Warning and Precaution about this risk to the labels of all medicines in this drug class, called dipeptidyl peptidase-4 (DPP-4) inhibitors.
Patients should not stop taking their DPP-4 inhibitor medicine, but should contact their health care professional right away if they experience severe and persistent joint pain. Health care professionals should consider DPP-4 inhibitors as a possible cause of severe joint pain and discontinue the drug if appropriate.
Insulet Corporation initiated a lot-specific voluntary recall of 40,846 boxes (10 Pods per box) of the OmniPod (Pod) Insulin Management System. This field corrective action is due to the possibility that some of the Pods from these lots may have a higher rate of failure than Insulet’s current manufacturing standards. This recall does not affect the OmniPod Personal Diabetes Manager (PDM).
There are two ways in which these Pods can fail at a rate that is higher than Insulet’s current standard. The cannula may either completely retract or fail to fully deploy, which may result in the patient not receiving the expected insulin dose. Or the Pod may trigger an audible alarm indicating it will no longer deliver insulin and will need to be replaced. Both situations can result in the interruption of insulin delivery that can cause hyperglycemia, which, if left untreated, can result in diabetic ketoacidosis (DKA).
OmniPods from the affected lots were distributed to customers from December 2013 to March 2015.
Allergan announced that it is conducting a voluntary recall down to consumer level of specific lots of its Refresh Lacri-Lube 3.5g and 7g for dry eye, Refresh P.M. 3.5g for dry eye, FML (fluorometholone ophthalmic ointment) 0.1% (sterile ophthalmic ointment topical anti-inflammatory agent for ophthalmic use, 3.5g), and Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile topical ophthalmic ointment combining an antibacterial and a corticosteroid, 3.5g.
FDA is warning about reports of severe allergic reactions and herpes zoster (shingles) associated with the use of Picato gel (ingenol mebutate). FDA received reports of cases involving severe eye injuries and skin reactions associated with the application of Picato gel. Some cases were associated with Picato gel not being used according to the instructions for use on the label. As a result, FDA is requiring changes to the label to warn about these new safety risks and to provide additional instructions on the safe and appropriate application of the product. See the FDA Drug Safety Communication for additional information and recommendations.
Patients should use Picato gel as prescribed by their health care professionals, and should not use it on an area of skin larger or for a longer period than instructed in the drug label. Also patients should avoid applying the gel in, near, and around the mouth, lips and eye area. Accidental transfer of Picato gel from the hands even after washing has occurred, including through application of make-up and insertion of contact lenses. Applying Picato gel in a manner other than recommended in the product label has been associated with severe skin reactions and eye injuries.
The allergic reaction may include throat tightness, difficulty breathing, feeling faint, or swelling of the lips or tongue.
FDA is alerting health care professionals not to administer to patients compounded or repackaged drugs that have been stored in 3 milliliter (ml) and 5ml syringes manufactured by Becton-Dickinson (BD) unless there is no suitable alternative available. Preliminary information indicates that drugs stored in these syringes may lose potency over a period of time due to a possible interaction with the rubber stopper in the syringe.
If you have been using products packaged in these syringes, be aware that using a substitute product may require a dosage adjustment in case the patient has been receiving a subpotent product, or adverse consequences could occur.
BD’s 10ml, 20ml and 30ml syringes may also contain the same rubber stopper. The company is alerting their customers not to use these syringes as a closed container system for compounded and repackaged drugs.
The company received reports that when the OxyTote is mishandled or dropped, the oxygen cylinder may ignite causing an internal flash fire and the canister to burst. See FDA Recall notice for a list of affected Lot and Model numbers.
The firm has received a total of 2 reports of incidents in which the device has malfunctioned, including 1 injury and 1 death. When the injury occurred, the unit was dropped from 4 feet; where the death occurred, the employee did not drop the gas cylinder, but set it down by his side.
Hartley Medical is voluntarily recalling three lots of Prolotherapy with Phenol, Injectable to the hospital/user level due to non-sterility concerns.
Blue Square Market Inc. of North Huntingdon, PA, is recalling “Kaboom Actions Strip 12 Pack” and LiDa DaiDaiHua to the user level after FDA analysis revealed the products contain undeclared active pharmaceutical ingredients. Kaboom was found to contain sulfoaildenafil and LiDa DaiDaiHua was found to contain sibutramine and phenolphthalein.
Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 due to increased risk of heart attacks and strokes. Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States.
Cook Medical has received complaints that the catheter tip may split or separate from the catheter. If this occurs, the tip could enter the patient’s bloodstream. This could cause serious injury to the patient and require additional medical intervention to retrieve the tip, or cause death. Tip splitting or separation may also cause the device to stop working.
- Beacon Tip Torcon NB Advantage Catheters
- Beacon Tip Royal Flush Plus High-Flow Catheters
- Slip-Cath Beacon Tip Catheters
FDA is alerting health care providers, patients, and caregivers about serious adverse events associated with LVADs. These adverse events include an increased rate of pump thrombosis (blood clots inside the pump) with Thoratec’s HeartMate II and a high rate of stroke with the HeartWare HVAD since approval of the devices. FDA is also aware of bleeding complications related to both the Thoratec HeartMate II and HeartWare HVAD.
When used for the currently approved indications in appropriately selected patients, FDA believes the benefits of these LVADs continue to outweigh the risks. However, the FDA also believes it is important for health care providers and patients to be aware of this important information when considering the use of these devices and clinical management of their patients.
FDA is warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS). These are the first cases of PML reported in patients taking Gilenya who had not been previously treated with an immunosuppressant drug for MS or any other medical condition. As a result, information about these recent cases is being added to the drug label.
Gilenya is an immunomodulator shown to benefit patients with relapsing forms of MS. This type of MS causes attacks or relapses, which are periods of time when symptoms get worse. Immunomodulators alter the immune system to reduce inflammation. PML is a rare and serious brain infection caused by the John Cunningham (JC) virus. The JC virus is a common virus that is harmless in most people but can cause PML in some patients who have weakened immune systems, including those taking immunosuppressant drugs.
In an August 2013 Drug Safety Communication, FDA reported that a patient developed PML after taking Gilenya. PML could not be conclusively linked to Gilenya in this case because prior to Gilenya treatment the patient had been treated with an immunosuppressant drug that can cause PML and during Gilenya treatment the patient had received multiple courses of intravenous corticosteroids, which can weaken the immune system.
UPDATE 08/19/15: A possible third case has now been reported. The FDA is continuing to watch this closely.
The FDA, the U.S. Department of Homeland Security’s Industrial Control Systems Cyber Emergency Response Team (ICS-CERT), and Hospira are aware of cybersecurity vulnerabilities associated with the Symbiq Infusion System. FDA strongly encourages health care facilities transition to alternative infusion systems, and discontinue use of these pumps.
Hospira and an independent researcher confirmed that Hospira’s Symbiq Infusion System could be accessed remotely through a hospital’s network. This could allow an unauthorized user to control the device and change the dosage the pump delivers, which could lead to over- or under-infusion of critical patient therapies. The FDA and Hospira are currently not aware of any patient adverse events or unauthorized access of a Symbiq Infusion System in a health care setting.
Hospira has discontinued the manufacture and distribution of the Symbiq Infusion System, due to unrelated issues, and is working with customers to transition to alternative systems. However, due to recent cybersecurity concerns, the FDA strongly encourages health care facilities to begin transitioning to alternative infusion systems as soon as possible.
Unichem Pharmaceuticals (USA), Inc. (Unichem) is voluntarily recalling one lot of Hydrochlorothiazide Tablets 25 mg 1000-count bottle to the consumer level. This recall has been initiated as a precautionary measure due to the identification of a Clopidogrel tablet found in a bottle of the product.
The risk associated with mistakenly taking a Clopidogrel tablet instead of a Hydrochlorothiazide tablet is the increased probability of experiencing Clopidogrel’s side effects which include bleeding and/or bruising. Patients with active bleeding or who are allergic to Clopidogrel or any component of the formulation may experience more serious adverse health consequences as a result of unknowingly consuming Clopidogrel. Additionally, missing a dose of Hydrochlorothiazide could result in uncontrolled blood pressure or swelling caused by excess fluid (edema). As per Unichem’s internal investigation, this episode is an isolated event noted at one pharmacy and confined to the recalled lot. Unichem has not received any reports of adverse events related to this recall to date.
FDA is warning health care professionals and patients that reports of confusion between the antidepressant Brintellix and anti-blood clotting medication Brilinta have resulted in the wrong medication being prescribed or dispensed. FDA determined that the main reason for the confusion between these two medications is the similarity of their brand (proprietary) names. None of the reports indicates that a patient ingested the wrong medication; however, reports of prescribing and dispensing errors continue.
FDA is investigating the risk of brain deposits following repeated use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). Recent publications in the medical literature have reported that deposits of GBCAs remain in the brains of some patients who undergo four or more contrast MRI scans, long after the last administration. It is unknown whether these gadolinium deposits are harmful or can lead to adverse health effects.
FDA, including its National Center for Toxicological Research (NCTR), will study this possible safety risk further. FDA is working with the research community and industry to understand the mechanism of gadolinium retention and to determine if there are any potential adverse health effects. Based on the need for additional information, at this time, FDA is not requiring manufacturers to make changes to the labels of GBCA products.
Teva Parenteral Medicines announced a voluntary recall of six lots of Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of particulate matter identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals. Administration of an intravenous product with particulate matter has the potential to result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which may be life-threatening if vital organs are affected. To date, Teva has not received any reports of adverse events related to this recall.
Baxter International Inc. announced it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint. The matter was identified prior to patient administration and there have been no adverse events associated with this issue reported to Baxter.
Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs.
This recall affects Lot Numbers P319921 and P327635.
FDA is alerting health care providers and patients of reports of patient deaths and other serious adverse events associated with the use of the Lariat Suture Delivery Device and its associated devices to close the left atrial appendage, a pouch-like region of the left atrium in the heart, in patients with irregular heart rhythm (atrial fibrillation) to prevent stroke.
FDA identified 45 adverse events through June 30, 2015 that occurred in patients undergoing LAA closure procedures with the Lariat Suture Delivery Device and/or its associated devices. These reports describe 6 patient deaths and other serious medical complications including laceration and/or perforation of the heart, complete LAA detachment from the heart, bleeding (hemorrhage), low blood pressure (hypotension), fluid collection around the heart (pericardial effusion), fluid collection around the heart that causes low blood pressure and decreased heart function leading to shock (cardiac tamponade), and fluid collection around the lung (pleural effusion). Of the 45 adverse events reported to the FDA, 34 (approximately 75%) resulted in the need to perform emergency heart surgery.
The FDA will continue to monitor this issue and keep the public informed if significant new information becomes available.
The FDA is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. Based on FDAs comprehensive review of new safety information, FDA is requiring updates to the drug labels of all prescription NSAIDs. As is the case with current prescription NSAID labels, the Drug Facts labels of over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk. FDA will also request updates to the OTC non-aspirin NSAID Drug Facts labels. See the FDA Drug Safety Communication (Table 1) for a list of non-aspirin nonsteroidal anti-inflammatory drug products.
Prescription NSAID labels will be revised to reflect the following information:
- The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID.
- The risk appears greater at higher doses.
- It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.
- NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.
- In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.
- Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.
- There is an increased risk of heart failure with NSAID use.
Potential Counterfeit Diazepam Warning 07/06/2015
The FDA is warning consumers who purchase Diazepam, an anti-anxiety medication, on the internet of the potential risk that this drug may be counterfeit. The World Health Organization (WHO) has reported 700 adverse events from patients in Central Africa taking mislabeled Diazepam that was actually the anti-psychotic drug, Haloperidol. The patients who mistakenly took Haloperidol suffered acute contractions of the muscles of the face, neck and tongue (dystonia).
While it has not been confirmed that the counterfeit Diazepam in Africa was purchased online and FDA has no confirmed reports that these counterfeit products have entered the United States, FDA advises consumers who purchased Diazepam online to check if the pills they received are authentic. The counterfeit tablets are light yellow in color, scored across the center of the tablet on one side and bear the letters AGOG on the other side.
The oxygen intake port may be blocked which can prevent the bag from filling. This may prevent the device from delivering breathing support to the patient. A delay in treatment may potentially lead to patient injury or death.
On May 14, 2015, Teleflex sent an urgent medical device recall letter to customers asking them to immediately discontinue use and quarantine the recalled product. Customers are asked to return any affected product together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. The letter also requested a sub-recall of the product through the distributers instructing them to immediately discontinue distribution and quarantine the recalled products, and notify their customers who have received the product of the recall.
FDA is investigating the safety of using codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for serious side effects, including slowed or difficult breathing.
Children, especially those who already have breathing problems, may be more susceptible to these serious side effects. In 2013, FDA warned against using codeine in children who recently had surgery to remove their tonsils and/or adenoids.
In April 2015, the European Medicines Agency (EMA) announced that codeine must not be used to treat cough and cold in children under 12 years, and that codeine is not recommended in children and adolescents between 12 and 18 years who have breathing problems, including those with asthma and other chronic breathing problems.
FDA will continue to evaluate this safety issue and will consider the EMA recommendations. Final conclusions and recommendations will be communicated when the FDA review is complete.
FDA announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear pain, infection, and inflammation. The unapproved prescription ear drops contain active ingredients such as benzocaine and hydrocortisone, and have not been evaluated by the FDA for safety, effectiveness and quality. The labels on these products do not disclose that they lack FDA approval, and health care professionals may not be aware of their unapproved status.
Unapproved prescription otic drug products are frequently given to young children suffering from ear infections and other conditions that cause ear pain and swelling. Patients taking unapproved drugs may be at greater risk because there is no proven safety or effectiveness information. These products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labeled directions for use.
Unapproved prescription otic drug products containing the following ingredients are covered by this action:
- benzocaine and antipyrine;
- benzocaine, antipyrine, and zinc acetate;
- benzocaine, chloroxylenol, and hydrocortisone;
- chloroxylenol and pramoxine; and
- chloroxylenol, pramoxine, and hydrocortisone.
A federal judge for the District of New Jersey has entered a consent decree of permanent injunction between the United States and Acino Products LLC (Acino), of Hamilton, New Jersey, and the company’s president, Ravi Deshpande, for marketing unapproved and misbranded prescription drugs.
The U.S. Department of Justice brought the action on behalf of the U.S. Food and Drug Administration.
According to the complaint, Acino marketed unapproved prescription drugs, hydrocortisone acetate 25 mg suppositories under the brand names Rectacort-HC and GRx HiCort 25, for treatment of medical conditions including inflamed hemorrhoids, chronic ulcerative colitis, and other inflammatory conditions.
Rectacort-HC and GRx HiCort 25 have not been approved by the FDA. In addition, these prescription drugs are misbranded because their labeling fails to carry adequate directions for use. Unapproved new drugs and misbranded drugs have not been shown to be safe and effective, may be of uncertain quality, and may pose risks to patients.
FDA is providing notification of a Class I recall of FLOW-i Anesthesia Systems by Maquet. The firm has received several complaints where patient cassettes, which are the center of gas flow in the system, have come loose. The patient cassette locking device may accidentally release the patient cassette from its mount when users perform a change of system. This may cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately.
The firm has received 10 reports this device has malfunctioned; no injuries or deaths have been reported.
A process monitoring failure led to higher than expected amounts of manufacturing residues left on the Zimmer M/L Taper with Kinectiv Technology Femoral Stems and Necks. These residues can cause serious adverse health issues including allergic reactions, pain, infections, or death. Use of these products may require the need for a revision surgery to replace the affected implant. Manufacturing and distribution dates: March 31, 2015 through April 20, 2015. See Recall Notice for affected lot numbers.
The Zimmer M/L Taper with Kinectiv Technology Femoral Stems and Necks are Tivanium alloy implants used for hip replacements that allow the surgeon to fit the implant specifically to the patient. During hip replacement surgery, the damaged portions of the hip joint are removed and replaced with an integrated system of products, which includes the femoral stem and neck. Recall Initiated on June 8, 2015.
Based on reviews of additional safety reports from patients treated with the anti-seizure drug Potiga (ezogabine), the FDA has determined that the potential risks of vision loss due to pigment changes in the retina and of skin discoloration can be adequately managed by following the current recommendations in the Potiga labeling. To further explore any potential long-term consequences of these pigment changes, FDA has required the Potiga manufacturer, GlaxoSmithKline, to conduct a long-term observational study.
FDA review of additional safety reports does not indicate that the pigment changes in the retina observed in some patients affect vision. Skin discoloration associated with the use of Potiga appears to be a cosmetic effect and does not appear to be associated with more serious adverse effects. Therefore, a modification of the Risk Evaluation and Mitigation Strategy (REMS) is not needed at this time to ensure that the benefits of Potiga outweigh the risks of retinal and skin pigment changes. FDA expects that the required long-term observational study will provide further information on whether pigment changes in the retina caused by Potiga can lead to vision loss or other long-term side effects. In addition, the study should provide more information on the relationship between pigment changes in the retina and skin discoloration.
Mylan is expanding its voluntary nationwide recall to the hospital/user level of select lots of Gemcitabine for Injection and Methotrexate Injection products due to the presence of visible foreign particulate matter observed during testing of retention samples.
SmartLipo365 is voluntarily recalling 122 lots of Smart Lipo (800, 900, 950 mg) capsules, to the consumer level. FDA received samples of 800 and 900mg capsules of Smart Lipo and the lab results found the Smart Lipo products to contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein.
Baxter International Inc. announced today it is voluntarily recalling four product codes of its Vascu-Guard Peripheral Vascular Patch. Baxter received customer complaints of difficulty in distinguishing the smooth from rough surface of the Vascu-Guard patch as described in the labeled instructions for use. This is due to a deviation in the surface texture of the vascular patch in a new packaging configuration. Incorrect orientation of the patch with the rough side toward the bloodstream may increase the risk of vessel thrombosis and/or embolism.
The FDA has reviewed information that suggests unintentional injection of soft tissue fillers into blood vessels in the face can result in rare, but serious side effects. Unintentional injection can block blood vessels and restrict blood supply to tissues. Sometimes this can result in embolization. This means the filler material has traveled to other parts of the body. This can cause vision impairment, blindness, stroke and damage and/or death of the skin (necrosis) and underlying facial structures.
While unintentional injections into blood vessels may occur with injection sites anywhere on the face, the FDA’s review of literature and adverse event reports submitted to the FDA identifies certain injection locations where blood vessel blockage have been reported more often. These sites include the skin between the eyebrows and nose (glabella), in and around the nose, forehead, and around the eyes (periorbital region).
FDA is working with manufacturers to update their labeling. The requests asks that the labeling include additional warnings, precautions, and other statements about the risk of unintentional injection into blood vessels, consistent with the recommendations in this communication, so that both health care providers and patients would have a better understanding of the risks.
The recall is in response to a potential malfunction of an AVEA ventilator-specific 5 psi pressure transducer. The affected AVEA ventilators may develop a failure mode over a period of time, where, by design, the ventilator activates false Extended High Ppeak or Circuit Occlusion audio and visual alarms, opens the safety valve and stops ventilating. If this occurs, alternate ventilation support will be required to reduce the potential of hypoxemia or hypercapnia.
The global recall involves AVEA ventilators manufactured, serviced and distributed from July 1, 2011 to March 15, 2015. A list of affected model and serial numbers is available at the CareFusion website.
The company has notified customers of the recall with an urgent recall letter.
The FDA released a safety announcement warning that the Type 2 Diabetes medications, Canaglifozin, Dapaglifizin and Empagliflizon may lead to ketoacidosis – a serious condition where the body produces high levels of blood acids called ketones – and may require hospitalization. In a recent search of the FDA adverse reporting system database, 20 cases of acidosis, which was reported as diabetic ketoacidosis or ketosis, was found in patients who were treated with SGLT2 inhibitors from March 2013 to June 6, 2014 and all required emergency room visits or hospitalization for treatment. FDA is continuing to investigate to conclude whether changes are needed in this particular drugs prescribing information. The particular drug class FDA is investigating is called SGLT2 inhibitors, which are a class of prescription medicines used with diet and exercise to lower blood sugar in adults with Type 2 Diabetes.
The FDA announced a Class I Recall of all lots of the Tiger Paw System II by Maquet Medical Systems. Incomplete closure of the TigerPaw System II may result in tissue tears and/or bleeding, including a possible tear on the left atrial wall (top left chamber) during use of the device. Maquet Medical Systems received 51 reports of adverse events and one death.
The TigerPaw II is a surgical staple used to close tissue in the left atrial appendage (LAA) of the heart.
The affected devices were distributed April 1, 2013 through March 23, 2015.
Teva Parenteral Medicines issued a voluntary recall of eight lots of Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of particulate matter identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Administration of an intravenous product with particulate matter has the potential to result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which may be life-threatening if vital organs are affected.
Adrucil Injection is used in the palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas and is packaged in pharmacy bulk packages.
A recall has been issued for the LuSys Laboratories, Inc., Ebola Virus One-Step Test Kits because the FDA has not cleared or approved the kits for use or sale. The results obtained from these test kits have not demonstrated to be accurate and should not be used as in vitro diagnostic tests for Ebola infection. A false positive result may be life-threatening by potentially placing the patient in an isolation cohort with Ebola infected patients. A false negative test result may be life-threatening by causing a lack or delay in treatment of the patient and risking infecting healthcare providers, family and other close contacts.
The Endocrinologic and Metabolic Drugs Advisory Committee of the FDA voted to update the label, primarily on the increased risk for heart failure.
Baxter International Inc. is voluntarily recalling select lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter. Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the size, number, and composition of the foreign material, and patient’s underlying medical condition. In the absence of in-line filtration, these particles may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization. In high-risk patients this may lead to serious adverse health consequences.
The new warnings advise that there have been reports of suicide-related events in patients treated with ADHD drugs. The reports involved thoughts of suicide, suicide attempts, and in a very small number of cases, completed suicide. These events have been reported at various times during treatment, particularly at the start or during dose changes, and also after stopping the drug treatment.
Hepatitis C Treatments Containing Sofosbuvir in Combination With Another Direct Acting Antiviral Drug: Drug Safety Communication – Serious Slowing of Heart Rate When Used With Antiarrhythmic Drug Amiodarone 03/24/2015
Healthcare professionals should not prescribe either Harvoni or Sovaldi combined with another direct-acting antiviral drug with amiodarone. However, in cases where alternative treatment options are unavailable, FDA recommends heart monitoring in an inpatient hospital setting for the first 48 hours. Subsequently, monitoring in a doctor’s office or self-monitoring of the heart rate should be done every day through at least the first 2 weeks of treatment.
Zyprexa Relprevv (olanzapine pamoate): FDA Review of Study Sheds Light on Two Deaths Associated with the Injectable Schizophrenia Drug 03/23/2015
FDA has concluded a review of a study undertaken to determine the cause of elevated levels of the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate) in two patients who died. The study results were inconclusive. FDA is unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection.
The study suggested that much of the drug level increase could have occurred after death, a finding that could explain the extremely high blood levels found in the two patients who died 3 to 4 days after receiving injections of appropriate doses of Zyprexa Relprevv.
On the basis of all of the information reviewed (refer to the Drug Safety Communication for a full data summary), FDA is not recommending any changes to the current prescribing or use of Zyprexa Relprevv injection at this time. Patients should not stop receiving treatment without first talking to their healthcare professionals.
FDA is warning consumers not to rely on asthma products labeled as homeopathic that are sold over-the-counter (OTC). These products have not been evaluated by the FDA for safety and effectiveness.
Asthma is a serious, chronic lung condition. If asthma is not appropriately treated and managed, patients may have wheezing, shortness of breath, and coughing, and could be at risk for life-threatening asthma attacks that may require emergency care or hospitalization. Although there is no cure for asthma, there are many prescription asthma treatments approved by FDA as safe and effective, as well as some products that are marketed OTC in accordance with an FDA monograph.
Kraft Foods Group is voluntarily recalling approximately 242,000 cases of select code dates and manufacturing codes of the Original flavor of Kraft Macaroni & Cheese Dinner – due to the possibility that some boxes may contain small pieces of metal. The recalled product is limited to the 7.25-oz. size of the Original flavor of boxed dinner with the “Best When Used By” dates of September 18, 2015 through October 11, 2015, with the code “C2” directly below the date on each individual box. 03/18/2015
UltraZx, Labs, LLC is voluntarily recalling UltraZx a weight loss supplement. It has been found to contain undeclared Sibutramine and phenolphthalein. 03/11/2015
Sibutramine (Meridia), which was approved by the FDA in 1997 was withdrawn from the market on October 8, 2010 due to the risk of serious cardiovascular events (such as stroke and heart attack) based on information from a clinical study. Sibutramine is a medication that assists with weight-loss by altering neurotransmitters within the brain.
Phenolphthalein is a potent laxative, which acts within 6-8 hours and its effects may last 3-4 days. Phenolpthalein is suspected of causing genetic defects, damaging fertility or the unborn child, may cause cancer, kidney injuries and respiratory tract irritation.
The U.S. Food and Drug Administration today authorized use of Lixelle Beta 2-microglobulin Apheresis Column, the first device to treat dialysis-related amyloidosis (DRA).
FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack And Stroke 03/03/2015
[This information is an update to the FDA Drug Safety Communication: FDA Evaluating Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products issued on January 31, 2014.]
FDA is requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. FDA is also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. FDA cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.
Two recalls have been issued for the Teleflex Medical, MAQUET Servo Humidifier 163 for connector cracks and cracks in connector tubes. Some connector cracks were found when preparing patients for support with a ventilator. These cracks may lead to oxygen and other gases leaking from the ventilator and not delivering sufficient treatment to patients, potentially causing serious injury or death. Also, cracks were found in the connector tubes during the manufacturing process and some devices were distributed before the problem was identified.
The FDA has recently approved the VenaSeal Closure System to be marketed. 02/20/2015
The VenaSeal Closure System (VenaSeal System) is intended to permanently treat varicose veins of the legs that cause symptoms by sealing the affected veins that are closest to the skin (superficial varicose veins) with a cyanoacrylate-based adhesive. The VenaSeal System also consists of a catheter, guidewire, dispenser gun, dispenser tips, and syringes.
Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Atracurium Besylate Injection, USP, 50mg/5mL and 100mg/10mL due to FDA Observations Pertaining to Aseptic and GMP Practices at the Manufacturer’s Site Potentially Impacting Product Sterility 02/23/2015
Atracurium Besylate Injection is used adjunct to general anesthesia to facilitate endotracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
A manufacturing error caused the balloon inflation ports to be mislabeled. This may cause the physician using the device to deflate the balloons in the incorrect order. If this happens, there is a potential for blood clots to dislodge and move into the lungs. Depending upon the size of these clots, there is the possibility of serious patient injury or death.
A recall has been issued for the HeartWare Ventricular Assist System (VAS). A buildup of static may cause a sudden discharge of electricity (electrostatic discharge) in the device. When this happens, data in the motor controller that manages the pump’s operation may be corrupted and the device may stop working. This problem occurs more often in older model controllers distributed during the clinical trials.
The U.S. Food and Drug Administration today expanded the approved uses of Vyvanse (lisdexamfetamine dimesylate) to treat binge-eating disorder in adults. The drug is the first FDA-approved medication to treat this condition.
The Medtronic Melody Transcatheter Pulmonary Valve (TPV) is an artificial heart valve made from the jugular vein valve of a cow that is sewn into a small metal frame. The Medtronic Ensemble Transcatheter Valve Delivery System is a thin, hollow, and long tube (catheter) that delivers the Melody TPV into the heart without open heart surgery while the heart is beating.
The U.S. Food and Drug Administration today approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease (GERD) in adults and children ages 1 and older. Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach. 1/26/2015
Ivax Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceuticals USA, has gained approval to market esomeprazole in 20 and 40 milligram capsules.
Esomeprazole capsules are also approved to reduce the risk of gastric ulcers associated with use of nonsteroidal anti-inflammatory drugs (NSAIDs), treat the stomach infection Helicobacter pylori along with certain antibiotics, and to treat conditions where the stomach makes too much acid, including Zollinger-Ellison syndrome.
FDA approved Natpara (parathyroid horomone) to control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism, a rare disease that affects approximately 60,000 people in the United States. 1/23/2015
Hypoparathyroidism occurs when the body secretes abnormally low levels of parathyroid hormone, which helps regulate calcium and phosphorus levels in the body.
Hypoparathyroidism is caused by loss of function of the parathyroid glands and occurs most commonly as a result of surgical removal of the parathyroid glands and more rarely as a result of autoimmune or congenital diseases. Patients with hypoparathyroidism can experience numbness, tingling, muscle twitching, spasms or cramps, abnormal heart rhythm, and seizures as a consequence of low blood calcium levels.
Hypoparathyroidism is also associated with long-term complications such as kidney damage, kidney stones, development of cataracts and calcification of soft tissues.
Natpara, a hormonal injection administered once daily, helps to regulate the body’s calcium levels. The FDA granted Natpara orphan drug designation because it is intended to treat a rare disease.
Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients Under Age 18: FDA Safety Communication – Reports of Serious Injuries 1/21/2015
FDA is aware of healthcare providers using bone graft substitutes containing recombinant proteins or synthetic peptides in patients under age 18. Reports of serious injuries, such as excess bone growth, fluid accumulation, inhibited bone healing, and swelling, have increased the FDA’s concern.
FDA approved the Barostim neo Legacy System. This device includes a Implantable Pulse Generator (IPG) which is a device similar to a pacemaker and is implanted under the skin on the upper chest. 1/15/2015
FDA and the Centers for Disease Control and Prevention (CDC) are continuing to investigate multiple instances of Wallcur’s simulated intravenous (IV) saline products being administered to patients. These products are not sterile and should not be injected in humans or animals. So far, more than 40 patients have received infusions of the simulated saline products, and there have been many adverse events associated with these incidents including fever, chills, tremors and headache. Some patients were hospitalized, and there is one death associated with the use of these products; it is not known if this death is directly related to the use of the product.
The Alere INRatio Monitor System (INRatio Monitor or INRatio2 Monitor and INRatio Test Strips) may provide an INR result that is lower than expected result obtained using a laboratory INR method. Incorrect results can also occur if a patient has certain medical conditions. These conditions include, anemia, conditions associated with elevated fibrinogen levels, or unusual bleeding or bruising. Incorrect results can also occur if the instructions in the labeling for performing the test are not followed.
Valeant Pharmaceuticals North America LLC (VPNA) is issued a voluntarily recall of one lot of Virazole (ribavirin powder for solution), 100 mL, 6g Vial, 4-pack to the user level due to microbial contamination. 1/2/2015
The affected Virazole lot is Lot No. 340353F with an expiration date of Oct-2018.
FDA is aware of and understands the concerns arising from recent reports questioning the safety of prescription and over-the-counter pain medicines when used during pregnancy. The FDA evaluated research studies published in medical literatures and have determined they are too limited to make any recommendations based on the studies at this time.
Savaysa is manufactured by Daiichi Sankyo Co., Ltd., to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
Savaysa has a Boxed Warning that provides important dosing and safety information for health care professionals about specific patient groups, including a warning that Savaysa is less effective in atrial fibrillation patients with a creatinine clearance greater than 95ml per minute. Like other anti-clotting medications, Savaysa’s side effects were bleeding and anemia with the most serious side effect including life-threatening bleeding and there is no treatment that has been proven to reverse the anti-coagulant effect of Savaysa.
Savaysa has also been approved to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have already been treated with an anti-clotting drug administered by injection or infusion, for five to ten days.
The safety and efficacy of this drug in treating patients with atrial fibrillation that was not caused by cardiac valve disease was studied in a clinical trial of 21,102 participants. The trial results showed the higher dose of Savaysa to be similar to warfarin for the reduction in the risk of stroke.
Further, a study was conducts of at least 8,292 participants for treatment of patients with DVT and PE. In the trial, 3.2% of participants taking Savaysa had a symptomatic recurrent VTE compared to the 3.5% of those participants taking warfarin.
These products are for training purposes only. There have been reports of serious adverse events associated with the use of these products, i.e. Practi IV Solution Bags. FDA has become aware that some of these products were distributed to health care facilities and have already been administered to patients. Health care facilities are asked to carefully check the labels to make sure the products are not training products before administering. The FDA is continuing to work with the Centers for Disease Control and Prevention to inform health care professionals and state health departments.
U.S. Food and Drug Administration approved Rapivab (peramivir) to treat influenza infection in adults. 12/22/2014
Influenza, commonly known as the flu, is a contagious respiratory illness caused by influenza viruses. Flu infections can range from mild to severe and can sometimes lead to hospitalization and death. According to the Centers for Disease Control and Prevention (CDC), 5-20 percent of the American population gets the flu and more than 200,000 people are hospitalized from seasonal flu-related complications each year.
Rapivab is an inhibitor of influenza virus neuraminidase, an enzyme that releases viral particles from infected cells. Neuraminidase inhibitors are commonly used to treat flu infection. Rapivab is the first neuraminidase inhibitor approved for intravenous (IV) administration and is administered as a single IV dose. It is intended for patients 18 years and older who have acute uncomplicated influenza and have shown symptoms of flu for no more than two days.
The U.S. Food and Drug Administration today granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs. 12/22/2015
Melanoma is the fifth most common type of cancer in the United States. It forms in the body’s melanocyte cells, which develop the skin’s pigment. The National Cancer Institute estimates that 76,100 Americans will be diagnosed with melanoma and 9,710 will die from the disease this year.
Opdivo works by inhibiting the PD-1 protein on cells, which blocks the body’s immune system from attacking melanoma tumors. Opdivo is intended for patients who have been previously treated with ipilimumab and, for melanoma patients whose tumors express a gene mutation called BRAF V600, for use after treatment with ipilimumab and a BRAF inhibitor.
The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis. 12/19/2014
Viekira Pak contains three new drugs—ombitasvir, paritaprevir and dasabuvir—that work together to inhibit the growth of HCV. It also contains ritonavir, a previously approved drug, which is used to increase blood levels of paritaprevir. Viekira Pak can be used with or without ribavirin, but it is not recommended for patients whose liver is unable to function properly (decompensated cirrhosis).
FDA has approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI) and kidney infections (pyelonephritis). Zebraxa is the fourth new antibacterial drug product approved by the FDA this year. 12/19/2014
Zerbaxa is a combination product containing ceftolozane, a cephalosporin antibacterial drug, and tazobactam, a beta-lactamase inhibitor.
The 0.9% Sodium Chloride Injection USP in 100mL MINI-BAG PLUS Container is a sterile, nonpyrogenic solution for intravenous administration after admixture with a single dose of powdered drug. Baxter International, Inc. initiated a recall in the US of two specific lot numbers P317842 and P317891 due to particular matter that was identified as a fragment of the frangible form the vial adapter. This was identified upon standard visual inspection prior to patient administration. Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. In the absence of in-line filtration, particles may cause; local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization (blockage or blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver).
FDA is warning that the antipsychotic drug, ziprasidone, which is marketed under the brand name, Geodon and its generics, is associated with a rare but serious skin reaction that can progress to affect other parts of the body. A new warning has been added to the Geodon drug label to describe the serious condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
DRESS may start as a rash that can spread to all parts of the body. It can include, fever, swollen lymph nodes, and inflammation of organs such as the liver, kidney, lungs, heart or pancreas. DRESS can also cause a higher-than-normal number of a particular type of white blood cell called, eosinophils in the blood. DRESS may also lead to death. FDA has reviewed information from 6 patients in whom the signs and symptoms of DRESS appeared between 11 and 30 days after ziprasidone treatment was started; none of these patients died
Gardasil 9 is a vaccine approved for use in females’ ages 9 through 26 and males ages 9 through 15. It is approved for prevention of cervical, vulvar, vaginal and anal cancers caused by HPV (Human Papillomavirus) 16, 18, 31, 33, 45, 52 and 58 and for prevention of genital warts cause by HPV types 6 or 11. The new Gardasil 9 adds protection against 5 additional HPV types (31, 33, 45, 52 and 58) which cause approximately 20% of cervical cancers and are not covered by previously FDA-approved HPV vaccines.
The Alere INRatio® and INRatio®2 PT/INR Professional Monitoring System, consisting of the Alere INRatio® and INRatio®2 PT/INR Monitor and the Alere™ INRatio® Test Strip, is intended for use in the quantitative determination of International Normalized Ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals. The Alere INRatio® and INRatio®2 PT/INR Professional Monitoring System is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio® and INRatio®2 PT/INR Monitoring System is not intended to be used for screening purposes and is not intended for use in patients who are transitioning from heparin treatment to warfarin therapy.
Since Philips Healthcare’s original May 2014 recall, the firm has received 12 new complaints of visible mold on their devices, including one injury.
Two commonly-found molds were detected: Cladosporium and Penicillium Fungi. Cladosporium has been known to cause several different types of serious infections, including skin, eye, sinus, and brain infections especially in weakened or critically ill patients. Cladosporium and Penicillium Fungi can also cause difficulty in breathing or an allergic reaction.
Neonatal intensive care unit (NICU) patients and pediatric intensive care unit (PICU) patients are much more sensitive to molds and once the outer packaging is opened, there is also the potential for the mold to be transferred to the NICU and PICU.
Gel-E Donut is a non-toxic, gel filled positioning product that helps alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated.
Squishon products are made from a soft, breathable material and filled with on-toxic gel and provide a soft, pliable cushion to support and cradle a baby’s head and/or body. The rectangular shape allows for head movement while maintaining surface support.
Complaints of Empty Capsules. Gabapentin is a medication used as an anticonvulsant and analgesic. It was originally developed to treat epilepsy, and is currently also used to relieve neuropathic pain and to control seizures. It is recommended as a first line agent for the treatment of neuropathic pain arising from diabetic neuropathy, nerve pain from shingles, post-herpetic neuralgia, and central neuropathic pain. This medication is also prescribed for off-label use to treat, restless leg syndrome anxiety disorders, insomnia and bipolar disorders.
A recall has been issued for Siemens Healthcare Diagnostics, Rapid Gram Negative Combo Panels. Incorrect test results may occur for the following antibiotics: Aztreonam, Cefotaxime, Ceftazidime, and Ceftriaxone. The test may report certain bacteria as sensitive to one of these antibiotics when the bacteria are actually resistant. Using these recalled devices may cause ineffective patient treatment, and in rare instances may contribute to death.
The Plum A+ and A+3 infusion pumps have an alarm that should sound when a therapy is interrupted. Some of the alarms may fail to sound in situations that should trigger it. It is possible for a long delay before a health care professional becomes aware of the need to restore therapy. For patients receiving critical intravenous medication, there is a risk of injury or death resulting from this prolonged interruption in therapy.